Quality Management System with CAPA tracking, audit management, and deviation logging.
The QMS & CAPA module provides a comprehensive quality management system with CAPA tracking, audit management, deviation logging, and quality event management. It ensures continuous quality improvement through structured root cause analysis, action plan tracking, and effectiveness verification.
Explore the module's workflow through interactive interface mockups showing each step of the process.
Track CAPAs from identification through root cause analysis, action plan, implementation, and effectiveness verification.
CAPA-001
Site D data entry errors
CAPA-002
Lab sample labeling issue
CAPA-003
Protocol deviation trend
CAPA-004
Consent form version error
CAPA-005
Training gap at Site B
Structured deviation logging with severity classification, impact assessment, and corrective action linkage.
| Deviation ID | Description | Severity | Impact | CAPA |
|---|---|---|---|---|
| DEV-001 | Visit window exceeded by 3 days | Minor | No data impact | CAPA-001 |
| DEV-002 | Wrong protocol version used | Major | Subject re-consent | CAPA-005 |
| DEV-003 | Lab sample not centrifuged | Major | Sample rejected | CAPA-002 |
| DEV-004 | AE reported 2 days late | Serious | Expedited report filed | None |
| DEV-005 | CRF by unauthorized staff | Major | Data re-verified | CAPA-003 |
Quality performance indicators with trend analysis and benchmarking across studies.
Open CAPAs
12
4 implementing
Mean CAPA Age
28 days
Within 45-day target
Deviations (Month)
18
-22% vs last month
Effectiveness Rate
94%
Above 90% target
How QMS & CAPA integrates with other CTMS modules in the platform.
Quality issues escalate to CAPA
Monitoring findings generate CAPAs
Monitoring findings linked to CAPA
CAPA records available for inspections
Quality metrics tracked per study